Q. Is CBD a pain management alternative to opioids?
CBD or cannabinoid itself is non-psychoactive. Preliminary research indicates CBD or cannabidiol could be a successful opioid alternative. Recent studies have shown that states with medical marijuana laws (THC and CBD) have twenty-five percent (25%) fewer opioid-related deaths than states that have not implemented laws. Studies also show that CBD has a diminishing effect on drug cravings, which could impact the high relapse rates associated with opioids. While some studies are encouraging, it’s also important to understand why CBD shows so much promise to fight the opioid crisis. Education is key as CBD or cannabidiol continues to emerge as a pain management solution. CBD offers an opioid alternative for the treatment of chronic pain. Just last year, a study from the European Journal of Pain showed that (using an animal model) CBD applied on the skin could help lower pain and inflammation due to arthritis.
Q. Will CBD alone get a patient high?
No. Scientifically and clinically, hemp plants contain less than 0.3% tetrahydrocannabinol (“THC”), the psychoactive chemical found in cannabis. This minute amount of THC will not make a patient feel high, reducing the risks of theft, addiction, and diversion associated with THC use.
Q. What is the FDA position on CBD?
To date, only one prescription medication containing CBD has been approved by the FDA – Epidiolex, a drug used to treat some forms of epilepsy. The FDA has historically issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). Interestingly, the FDA has tested the chemical content of cannabinoid compounds in some of the products and many were found to not contain the levels of CBD they claimed to contain. CBD products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Notices and warnings related to promised outcomes of the effectiveness of CBD products should be considered before promoting or offering any CBD product for sale. The FDA held its first public hearing on how regulation should be implemented on May 31, 2019, and in the future, will regulate CBD products. The goal of the May 2019 public hearing was for the FDA to learn about the current status of the safety, manufacturing, product quality, marketing, labeling, and sale of products containing CBD.
Q. How do you know what’s in the bottle labeled CBD?
Currently, the manufacturing of CBD is unregulated. According to the Centers for Disease Control (CDC), synthetic products marketed as CBD sickened at least 52 people in Utah last winter, sending 31 of them to emergency rooms. This lack of regulatory oversight creates a certain level of ongoing risks.
Q. Why CBD or cannabidiol?
Many patients have reported pain management success when using CBD products. As research on CBD products and effects continues, owners must continue to monitor published research to determine if the CBD products offered remain safe and beneficial. To date, there is no recognized research to support CBD products for use as an appropriate treatment for serious medical conditions like cancer, diabetes, and Alzheimer’s disease. However, CBD is commonly used to address anxiety and insomnia, with some supportive research for these ailments.
Q. Demand for CBD products?
Before implementation of a CBD regimen, patients should consult his/her primary care physician for guidance. Once approved, patients should start usage of CBD in small doses, after first confirming the CBD product is a “quality product.”
Q. How do you determine whether a CBD product is a quality product?
Before offering a CBD product for sale, check the manufacturer, source, or grower of the CBD, and the amount of THC present. Additionally, it is important to check for a “Whole Plant” or “Full Spectrum” Label (another quality of a good CBD oil is that it is manufactured using the whole plant). Finally, verify the existence of third-party lab results. Consulting and offering CBD products can feel intimidating at first, but with due diligence you’ll be ready to advise and assist patients seeking a quality product.
Q. What are best practices when offering CBD Products?
Always verify that the individual has sought the counsel and guidance of his/her primary care physician; research origins of all products being offered; review and provide the user with literature from lab, manufacturer, and grower; recommend the user to start out with small doses; and advise the user of any potential side effects which may include nausea, fatigue, and irritability.
Q. Should owners know the laws in their state?
All 50 states have laws legalizing CBD with varying degrees of restriction and, while the federal government still considers CBD in the same class as marijuana, it doesn’t habitually enforce regulations against CBD distribution and/or usage. Owners interested in offering CBD products should verify legal restrictions in their respective state and understand that the laws regulating CBD sale and usage are constantly changing.
Anthony J. Calamunci, Esq., FisherBroyles
Anthony’s 24 years of healthcare law experience includes the representation of healthcare clients, such as pharmacies, drug manufacturers, wholesalers, distributors, physicians, physician groups, imaging centers, sleep centers, and laboratories relating to compliance, litigation, and regulatory matters. He also provides clients with strategic advice on how to adjust their operations to keep pace with the always changing healthcare industry. Anthony further has become active in the hemp, CBD, or cannabidiol industry advising growers, processers, manufactures, and providers. Anthony works with clients assisting as litigation counsel in adversary proceedings against third-party payers, PBMs, Government Agencies, and BOP. He also counsels on practice formations and sales, fraud and abuse, and Stark counseling, buy-sell agreements, employment issues, large group practice mergers, HIPAA compliance, and governmental, professional board, and medical staff investigations. Because so much of healthcare law is federal in nature, Anthony has clients across the country, and has a national presence.